NCT00996801

MK-5442 in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate (MK-5442-012)

A Phase IIb, Randomized, Double-Blind, Placebo- and Active-Controlled, Dose-Range-Finding Study to Evaluate the Effects of MK-5442 on Bone Mineral Density (BMD) in the Treatment of Osteoporosis in Postmenopausal Women Previously Treated With an Oral Bisphosphonate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 526 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: Female
• Age: 45 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to demonstrate that additional gain in bone mineral density (BMD) can be achieved by switching to MK-5442 from an oral bisphosphonate in participants who have been receiving oral bisphosphonate therapy for at least 3 years.

Detailed description

The study was originally planned for a duration of 2 years and included efficacy analysis of a 15 mg MK-5442 treatment arm. Amendment 1 of the protocol eliminated the 2nd year of the study as well the 15-mg arm. Enrollment into the 15-mg MK-5442 arm was stopped as a result of the amendment and all participants who had been randomly assigned to the MK-5442 15-mg treatment arm were discontinued from the study.

Conditions

• Osteoporosis
• Postmenopausal Osteoporosis

Interventions

Type	Name	Description
DRUG	MK-5442	MK-5442 tablets (randomized to a dose of 5, 7.5, 10 or 15 mg) taken orally, once-daily, for 12 months
DRUG	Placebo to MK-5442	Matching placebo to MK-5442 taken orally, once-daily, for 12 months
DRUG	Alendronate Sodium	Alendronate tablets 70 mg, taken orally, once-weekly, for 12 months
DRUG	Vitamin D3	Vitamin D3 (cholecalciferol) administered orally, at a dose of 5600 IU (two tablets, 2800 IU each), once-weekly for 12 months
DRUG	Calcium carbonate	Participants who qualify (those who have a calcium intake of less than 1200 mg/day) will receive oral supplemental calcium carbonate, at a dose of either 400 mg or 500 mg, once-daily, for 12 months
DRUG	Placebo to Alendronate	Placebo to alendronate once-weekly for 12 months

Timeline

• Start date: 2009-11-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2009-10-16
• Last updated: 2016-01-22
• Results posted: 2012-11-16